AGILIA INFUSION SYSTEM
FDA 510(k) clearance K121613 · decided 2013-05-01
Clearance details
- K-number
- K121613
- Device name
- AGILIA INFUSION SYSTEM
- Applicant
- Fresenius Kabi AG
- Decision
- Substantially Equivalent
- Date received
- 2012-06-01
- Decision date
- 2013-05-01
- Days to decision
- 334 days
- Clearance type
- Traditional
- Product code
- FRN
- Device class
- 2
- Regulation number
- 880.5725
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Lake Zurich, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| VOLUMAT MC AGILIA US, Infusion Pump, REF Z021135, software versions 1.7 and 1.9a Product U recall (Z-2064-2019) | Fenwal Inc | 2019-08-12 |